Devices and methods for oral hygiene

ABSTRACT

This application relates to oral hygiene and/teeth cleaning devices and associated methods. The devices can be configured to have a shape that allows all or substantially all of a user&#39;s teeth to be cleaned at once. In some embodiments, the devices are configured to be useable, for example, without access to water or a bathroom. The devices can be used to freshen up and clean the user&#39;s mouth on-the-go. In some embodiments, the devices are disposable.

PRIORITY APPLICATIONS

This application is a continuation-in-part of U.S. application Ser. No. 16/459,301, filed Jul. 1, 2019, which claims priority to U.S. Provisional Application No. 62/693,332, filed Jul. 2, 2018, and this application also claims priority to U.S. Provisional Application No. 63/082,758, filed Sep. 24, 2020, each of which are incorporated by reference herein. Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57.

BACKGROUND Field

This application relates to oral healthcare, and in particular, to devices and methods for maintaining oral hygiene, cleaning teeth, and/or freshening the mouth.

Description

Oral hygiene is important for many reasons, including, for example, preventing dental decay and gum disease, and keeping breath fresh. Generally, people brush, floss, and use mouthwash to keep their mouth and teeth clean.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present disclosure will become apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only several embodiments in accordance with the disclosure and are not to be considered limiting of its scope, the disclosure will be described with additional specificity and detail through use of the accompanying drawings.

FIG. 1A is a perspective view of an embodiment of an oral hygiene device that includes an H-shaped cross-section.

FIG. 1B is a perspective view of an embodiment of an oral hygiene device that includes a U-shaped cross-section.

FIG. 2A is a top and side perspective view of an embodiment of an oral hygiene device that includes a plurality of ribs for cleaning top and bottom teeth at substantially the same time.

FIG. 2B is a bottom and side perspective view of the oral hygiene device of FIG. 2A.

FIG. 2C is a top and front perspective view of the oral hygiene device of FIG. 2A.

FIG. 2D is a side view of the oral hygiene device of FIG. 2A.

FIG. 2E is a top view of the oral hygiene device of FIG. 2A.

FIG. 2F is a bottom view of the oral hygiene device of FIG. 2A.

FIG. 2G is a detail view of the oral hygiene device of FIG. 2A, showing an enlarged view of ribs of a bottom side of the oral hygiene device.

FIG. 3A is a top view of an embodiment of an oral hygiene device that includes dual hinges with the device shown in an open configuration.

FIG. 3B is a top view of the oral hygiene device of FIG. 3A that illustrates the device in a closed configuration.

FIG. 4A is a detail view of an embodiment of a locking mechanism for the oral hygiene device of FIG. 3A illustrated just prior to locking into place.

FIG. 4B is a detail view of the locking mechanism of FIG. 4A illustrated locked into place.

FIG. 5A is a perspective view of an embodiment of a container for an oral hygiene device.

FIG. 5B is a front view of the container of FIG. 5A and illustrates how the oral hygiene device may fit within the container.

FIG. 5C is a perspective view of another embodiment of a container for an oral hygiene device.

FIG. 6A is a top perspective view of an embodiment of an oral hygiene device that includes beads of mouthwash, breath freshener, toothpaste, desensitizing paste or gel, or whitening paste or gel.

FIG. 6B is a bottom perspective view of the oral hygiene device of FIG. 6A.

FIG. 6C is a top view of the oral hygiene device of FIG. 6A in an open configuration.

FIG. 6D is a top view of the oral hygiene device of FIG. 6A in a closed configuration.

FIG. 7A is a top and side perspective view of another embodiment of an oral hygiene device.

FIG. 7B is a bottom and side perspective view of the oral hygiene device of FIG. 7A.

FIG. 7C is a top and front perspective view of the oral hygiene device of FIG. 7A.

FIG. 7D is a side view of the oral hygiene device of FIG. 7A.

FIG. 7E is a top view of the oral hygiene device of FIG. 7A.

FIG. 7F is a bottom view of the oral hygiene device of FIG. 7A.

FIG. 7G is a first cross-sectional view of the oral hygiene device of FIG. 7A.

FIG. 7H is a second cross-sectional view of the oral hygiene device of FIG. 7A.

FIG. 7I illustrates a perspective view of the body of the oral hygiene device of FIG. 7A.

FIG. 7J is a back view of the oral hygiene device of FIG. 7A.

FIG. 7K is a front view of the oral hygiene device of FIG. 7A.

FIG. 8 is a top view of an embodiment of a formable oral hygiene device that is initially generally straight, but can be formed into a U-shape during use to fit to a user's teeth.

FIGS. 9A and 9B illustrates top views of another embodiment of an oral hygiene device including at least some portions that are formable in a straight configuration and a bent configuration, respectively.

FIGS. 10A and 10B illustrate views of another embodiment of an oral hygiene device including at least some portions that are formable in a straight configuration and a bent configuration, respectively.

FIGS. 11A and 11B illustrate views of another embodiment of an oral hygiene device including at least some portions that are formable in a straight configuration and a bent configuration, respectively.

FIG. 12A, 12B, 12C illustrate views of another embodiment of an oral hygiene device including at least some portions that are formable. FIG. 12A illustrates a top view in a straight configuration, FIG. 12B illustrates an inside view in a straight configuration, and FIG. 12C illustrates a top view in a bent configuration.

FIGS. 13A and 13B illustrate views of another embodiment of an oral hygiene device including at least some portions that are formable in a straight configuration and a bent configuration, respectively.

FIG. 14A is a perspective view illustrating an embodiment of a handle for an oral hygiene device.

FIG. 14B is a perspective view illustrating an embodiment of an oral hygiene device that includes two handles.

FIG. 14C is a perspective view illustrating an embodiment of an oral hygiene device that includes a contact point configured for manipulation of the device.

FIG. 14D is a perspective view of an oral hygiene device illustrating another embodiment of a handle for the device.

FIG. 15 is a top view of an embodiment of an oral hygiene device that includes a single hinge.

FIG. 16A is a perspective view of an embodiment of an oral hygiene device that includes a removable floss device that can also be used as a handle for the device.

FIG. 16B is a perspective view of another embodiment of an oral hygiene device that includes a removable floss device that can also be used as a handle for the device.

FIG. 17A illustrates a perspective view of an embodiment of a U-shaped oral hygiene device.

FIG. 17B illustrates a perspective view of another embodiment of a U-shaped oral hygiene device that includes a handle configured to receive a finger.

FIG. 17C illustrates a perspective view of another embodiment of a U-shaped oral hygiene device that includes a handle attached to the device by a joint.

FIG. 17D illustrates a perspective view of an embodiment of a U-shaped oral hygiene device that includes dual handles.

FIGS. 18A-18E illustrate view of another embodiment of an oral hygiene device.

FIGS. 19A-19M relate to testing of an oral hygiene device.

FIGS. 20A-20D relate to testing of an oral hygiene device.

FIG. 21 illustrates an embodiment of rib having a fanned portion.

FIGS. 22-23B illustrate embodiments of oral hygiene devices with enlarged handles.

Various features illustrated in the drawings may not be drawn to scale. Accordingly, the dimensions of the various features may be arbitrarily expanded or reduced for clarity. In addition, some of the drawings may not depict all of the components of a given system, method or device. Finally, like reference numerals may be used to denote like features throughout the specification and figures.

DETAILED DESCRIPTION

This application relates to oral hygiene and/or teeth cleaning devices and associated methods. The oral hygiene devices can be configured to have a shape that allows all or substantially all of a user's teeth (for example, all or substantially all of a user's upper teeth and/or all or substantially all of a user's lower teeth) to be cleaned at once. In some embodiments, the oral hygiene devices are configured to be useable, for example, without access to water or a bathroom. Thus, the oral hygiene devices can be used to freshen and clean the user's mouth on-the-go. In some embodiments, the oral hygiene devices are disposable.

The features, aspects, and advantages of the present application will now be further described with reference to the drawings of several embodiments, which are intended to be within the scope of the embodiments disclosed herein. These and other embodiments will become readily apparent to those skilled in the art from the following detailed description of the embodiments having reference to the attached figures, the development not being limited to any particular embodiment herein disclosed.

FIG. 1A is a perspective view of an embodiment of an oral hygiene device 100 a. The oral hygiene device 100 a can be useable to freshen a user's mouth and/or clean the user's teeth. The oral hygiene device 100 a includes a body 102. In the illustrated embodiment, the body 102 is generally U-shaped (e.g., comprises a general U-shape when viewed from above or below). The generally U-shaped body 102 can be configured to follow or conform to the shape of a user's upper and/or lower teeth. In some embodiments, the body 102 may be a tray configured in size and shape to fit into the user's mouth and over the upper and/or lower teeth. The body 102 may be made of a rigid, semi-rigid, or flexible material, such as plastics or rubbers. In some embodiments, the body 102 comprises a thermoplastic elastomer (TPE), high-density polyethylene (HDPE), polypropylene (PP), low-density polyethylene (LDPE), polyamides, polyolefin or other resins, polychloro-trifluoroethylene, various thermoplastics, and/or various elastomers. In some embodiments, the body 102 may comprise a food grade polypropylene. The composition of the body 102 is not limited to the above materials, but can be selected for specific characteristics including enough rigidity to provide general support and shape for the oral hygiene device 100 a, while also providing enough flexibility to allow the body 102 to fit to the particular anatomy of the user's mouth and teeth. In some embodiments, the oral hygiene device 100 a can be provided in a variety of sizes (e.g., small, medium, large, adult, or child) configured for use by users that have different size mouths. In some embodiments, the oral hygiene device 100 a can be provided in a size that is generally configured to fit most mouth sizes.

In the illustrated embodiment of FIG. 1A, the body 102 has a generally H-shaped cross-sectional profile 104. The generally H-shaped cross-sectional profile 104 can provide the body 102 with an upper channel 106 and a lower channel 108. The upper channel 106 can be configured to receive of be fitted over the user's upper teeth and the lower channel 108 can be configured to receive or be fitted over the user's lower teeth. For example, during use, the user may insert the oral hygiene device 100 a into the mouth such that the upper teeth are positioned within the upper channel 106 and the lower teeth are positioned within the lower channel 108.

One or more of the inside surfaces of the upper channel 106 and the lower channel 108 may include features for cleaning the user's teeth (or otherwise freshening the user's mouth). For example, the inside surfaces of the upper channel 106 and the lower channel 108 can include bristles, foam, rubberized fingers, ribs, textured surfaces, etc., configured to clean the teeth when the oral hygiene device 100 a is positioned within the mouth and moved back and forth and/or up and down. The teeth cleaning features are not shown in FIG. 1A, but examples will be shown and described below with reference to other embodiments.

In some embodiments, the teeth cleaning features within the upper channel 106 and the lower channel 108 are formed as part of the body 102. That is, in some embodiments, the teeth cleaning features can be integrally formed with the body 102. For example, the inside surfaces of the upper channel 106 and the lower channel 108 can be configured with a teeth cleaning texture that is molded into the body 102. In some embodiments, the teeth cleaning features can be made from the same material and/or formed at the same time as the body 102. For example, the body 102 and teeth cleaning features can be formed with a one-shot injection molding process in which a single material is injected into a mold to form the body 102 and teeth cleaning features simultaneously.

Advantageously, in some embodiments, the teeth cleaning features may comprise a different material than the body 102. For example, the teeth cleaning features may comprise a softer or more flexible material than the body 102. In such embodiments, the body 102 may be formed from a relatively stiffer or more rigid material in order to provide structural support for the device 100, and the teeth cleaning features can comprise a relatively more compliant or softer material in order to improve user comfort and cleaning efficiency. When made from different materials, the body 102 and the teeth cleaning features can be molded in a two-shot injection or overmolding process. For example, a first injection can be made using a first material to form the body 102, and then a second injection can be made using a second material to form the teeth cleaning features on the body 102.

The teeth cleaning features within the upper channel 106 and/or the lower channel 108 can be attached to the body 102 within the channels 106, 108. In the case of a two-shot injection or overmolding process, the teeth cleaning features are molded (and thereby connected) directly onto the body 102. In other embodiments, the body 102 and teeth cleaning features can be formed separately and then attached to each other, for example, with dental-grade adhesives.

In some embodiments, the upper channel 106 and the lower channel 108 can be lined with bristles, foam, rubberized fingers, ribs, etc., that are attached to the channels 106, 108. The shape, size, and combinations of the teeth cleaning features described herein are not limited to the above materials, but are selected for specific characteristics, including comfort to the mouth and gums and ability to clean teeth.

As illustrated in FIG. 1A, the oral hygiene device 100 a includes a handle 110. In the illustrated embodiment, the handle 110 is positioned on a front portion of the body 102. The user can hold the handle while inserting the oral hygiene device 100 a into the mouth and use the handle to manipulate the device (e.g., move the device up and down and/or back and forth) to use the device to clean his or her teeth. The handle 110 may be positioned and configured to extend out of the user's mouth between the user's lips when the oral hygiene device 100 a is positioned within the mouth.

To use the oral hygiene device 100 a, the user may use the handle 110 to insert the oral hygiene device 100 a into his or her mouth. The user may position the oral hygiene device 100 a such that the user's upper teeth are positioned within the upper channel 106 and the user's lower teeth are positioned within the lower channel 108. In this position, the upper and lower channels 106, 108 may contact the front, bottom, and back surfaces of the user's upper teeth and the front, top, and back surfaces of the user's lower teeth. Further, because of the generally U-shaped body the device 100 a can contact all or substantially all of the user's upper and/or lower teeth. As used herein, “contacting substantially all of the user's upper and/or lower teeth” can refer to contact at least 50%, at least 60%, at least 70%, at least 80%, or at least 90% of the user's upper and/or lower teeth.

With the oral hygiene device 100 a positioned within the mouth, the handle 110 may extend out of the user's mouth between the user's lips. Using the handle 110, the user may manipulate the oral hygiene device 100 a by moving the handle 110 back and forth (e.g., side to side or right and left) and/or up and down. Manipulating the oral hygiene device 100 a in this manner causes the teeth cleaning features within the upper channel 106 and the lower channel 108 to clean the teeth. After the user has used the device 100 a to clean the teeth, which can be done for an indicated period of time, for example, 10 seconds, 15 seconds, 20 seconds, 30 seconds, 1 minute, 1.5 minutes, or 2 minutes, the user can remove the oral hygiene device 100 a from the mouth. In some embodiments, the oral hygiene device 100 a is disposable, and can then be discarded.

Notably, in some embodiments, the oral hygiene device 100 a can be configured for use without requiring water. As such, the oral hygiene device 100 a can be used generally anywhere to quickly clean and/or freshen up the user's mouth, without requiring the user to access a bathroom or running water. To this end, the oral hygiene device 100 a can include dabs of mouthwash, breath freshener, toothpaste, desensitizing paste or gel as described below with reference to FIGS. 6A and 6B. In some embodiments, the dabs can be configured for use without requiring additional water. In some embodiments, the oral hygiene device 100 a is configured for a single use. For example, the user may use the oral hygiene device 100 a one time and then discard the device. In some embodiments, because the U-shaped body 102 covers many, and in some embodiments, all or substantially all of the user's teeth, the oral hygiene device 100 a may be able to clean all or substantially all of the user's teeth much quicker than a toothbrush, which generally only contacts a few (e.g., one, two, or three) teeth at a time and must be moved over all the teeth in order to clean the whole mouth.

FIG. 1B is a perspective view of another embodiment of an oral hygiene device 100 b. The oral hygiene device 100 b is similar in many respects to the oral hygiene device 100 a described above with reference to FIG. 1A. However, as shown in FIG. 1B, the oral hygiene device 100 b includes a body 102 with a generally U-shaped cross-sectional profile 112 (instead of the H-shaped cross-section 104 of FIG. 1A). The generally U-shaped cross-sectional profile 112 can provide a single channel 114 in the body 102 of the oral hygiene device 100 b (in contrast with the upper and lower channels 106, 108 of the oral hygiene device 100 a of FIG. 1A).

Similar to the description above, one or more of the inside surfaces of the channel 114 may include features for cleaning the user's teeth. For example, the inside surfaces of the channel 114 can include bristles, foam, rubberized fingers, ribs, textured surfaces, etc., configured to clean the teeth when the oral hygiene device 100 b is positioned within the mouth and moved back and forth and/or up and down. As described above, the teeth cleaning features can be formed as part of the body 102, molded onto the body in a two-shot injection or overmolding process, or attached to the body 102 within the channel 114 and can be made of the same or different materials than the body 102.

With the generally U-shaped cross-sectional profile 114, the oral hygiene device 100 b can be configured to clean either the user's upper teeth or the user's lower teeth at a time. In some instances, the device 100 b can then be flipped over to clean the other of the user's upper teeth or the user's lower teeth. For example, the user may use insert the oral hygiene device 100 b into the mouth such that the channel 114 is oriented in an upward direction and the user's upper teeth can be received within the channel 114. The user may then use the handle 110 to manipulate the device to allow the teeth cleaning features within the channel 114 to clean the user's upper teeth. The user may then remove the oral hygiene device 100 b, flip the device over (such that the channel 114 opens in a downward direction), and reinsert the device such that the user's lower teeth are received within the channel 114. The user may again manipulate the device 100 b such that the teeth cleaning features clean the user's lower teeth. Alternatively, the user may use the device 100 b to clean the lower teeth first, followed by the upper teeth. In some instances, the user may use two of the devices 100 b, one to clean the user's upper teeth and one to clean the user's lower teeth. FIGS. 7A-7K, described in more detail below, illustrate a more detailed example of an oral hygiene device 700 that can be used in this manner.

In some embodiments, the oral hygiene device 100 b may include teeth cleaning features positioned on a side 116 of the body 102 opposite the channel 114. With reference to the illustrated orientation, the side 116 may be the lower or bottom side of the device. For example, in addition to including teeth cleaning features within the channel 114, the oral hygiene device 100 b may also include teeth cleaning features (e.g., bristles, ribs, rubberized figures, foam, etc.) that extend from the lower side 116. Thus, in some embodiments, the oral hygiene device 100 b (with its generally U-shaped cross-sectional profile 112) can be configured to clean both the upper and lower teeth of the user at the same time.

FIGS. 2A-2G illustrate views of an embodiment of an oral hygiene device 200 that includes a plurality of ribs 218. The ribs 218 can be the teeth cleaning features described above. The ribs 218 can be positioned on the oral hygiene device 200 for cleaning upper and lower teeth at substantially the same time as shown in the illustrated embodiment. FIG. 2A is a top and side perspective view, FIG. 2B is a bottom and side perspective view, FIG. 2C is a top and front perspective view, FIG. 2D is a side view, FIG. 2E is a top view, FIG. 2F is a bottom view, and FIG. 2G is a detail view of the oral hygiene device 200.

With reference to FIGS. 2A-2G, the oral hygiene device 200 includes a body 202. In the illustrated embodiment, the body 202 is generally U-shaped similar to the oral hygiene devices described previously. For example, the generally U-shaped body 202 can be configured to generally follow the shape of a user's upper and/or lower teeth. As illustrated, the body 202 also includes a generally U-shaped cross-sectional profile, similar to the oral hygiene device 100 b described above. The generally U-shaped cross-sectional profile may include an inner wall 220, an outer wall 222, and a bottom wall 224 as shown. The generally U-shaped cross-sectional profile can define a channel 216 within the body 202. The channel 216 can be formed between the inner wall 220 and the outer wall 222 and bounded below by the bottom wall 224. In some embodiments, the body 202 can be configured in size and shape such that the channel 216 is configured to receive the user's upper teeth during use of the oral hygiene device 200. In some embodiments, the body 202 can be configured in size and shape such that the channel 216 is configured to receive the user's lower teeth during use of the oral hygiene device 200.

The body 202 may be made of a rigid, semi-rigid, or flexible material, such as plastic, rubber, a polymer, or other suitable material. In some embodiments, the body 202 is rigid enough to provide general support and shape for the oral hygiene device 200, while remaining flexible enough to allow the body 202 to fit to the particular anatomy of the user's mouth and teeth. In some embodiments, the body 202 comprises a thermoplastic elastomer (TPE), high-density polyethylene (HDPE), polypropylene (PP), low-density polyethylene (LDPE), polyamides, polyolefin or other resins, polychloro-trifluoroethylene, various thermoplastics, and/or various elastomers. In some embodiments, the body 102 may comprise a food grade polypropylene. The composition of the body 202 is not limited to the above materials, but is selected for specific characteristics including enough rigidity to provide general support and shape for the oral hygiene device 200, while including enough flexibility to allow the body 202 to fit to the particular anatomy of the user's mouth and teeth.

The body 202 may be formed such that the walls (e.g., the inner wall 220, the outer wall 222, and the bottom wall 224) are sufficiently thin so as to allow the body 202 to flex and conform to the shape of the user's mouth. For example, in some embodiments, the walls of the body 202 are about 2 mm, 1.5 mm, 1.0 mm, 0.75 mm, 0.5, or 0.25 mm thick. In some embodiments, the nominal thickness of the walls of the body 202 is about 1.2 mm. These thicknesses are provided by way of example, and the thickness of the walls of the body 202 can be selected to provide the desired characteristics described throughout this application.

In some embodiments, the oral hygiene device 200 can be provided in a variety of sizes (e.g., small, medium, large, adult, or child) configured for use by users that have different size mouths. In some embodiments, the oral hygiene device 200 can be provided in a size that is generally configured to fit most mouth sizes.

As illustrated, the oral hygiene device 200 includes a handle 210. The handle 210 can be configured as a tab, although other shapes are possible as described in greater detail below (see, for example, FIGS. 17A-17D). The handle 210 can extend from a front portion of the body 202 so as to be able to extend out of the user's mouth between the user's lips when the oral hygiene device 200 is inserted into the user's mouth. In the illustrated embodiment, the handle 210 extends form the outer wall 222 of the body 202. The handle 210 may be aligned with the bottom wall 224 of the body 202 (as shown), or the handle 210 can be placed in any other desired location. In some embodiments, the oral hygiene device 200 does not include a handle 210 (i.e., the handle 210 may be omitted). Similar to the discussion above, the user may use the handle to manipulate the oral hygiene device 200 to use the oral hygiene device 200 to clean the user's teeth.

Similar to the oral hygiene devices 100 a, 100 b described generally above, the oral hygiene device 200 can include teeth cleaning features (such as ribs 218) configured to clean the user's teeth when the device is used. In the illustrated embodiment, the teeth cleaning features comprise the ribs 218, although in other embodiments, other types of teeth cleaning features (e.g., foam, bristles, textured surfaces, etc.) can be used in addition to or in place of the ribs 218.

The ribs 218 can be formed of the same material as the body 202, or the ribs 218 can be formed of a softer or more flexible material than the body 202 as described above. Advantageously, forming the body 202 and the ribs 218 of different materials may improve functionality, comfort, and efficiency of the device. For example, as described above the body 202 can be formed of a generally stiffer and more rigid material to provide structural support for the device 200, while the ribs 218 can be formed of a generally less rigid or softer material. The softer material of the ribs 218 can provide more user comfort during use, while also better conforming to the user's mouth and teeth shape to provide increased cleaning efficiency.

The ribs 218 can be integrally formed with the body 202 or can be separately formed and attached to the body 202. In some embodiments, the body 202 and ribs 218 are co-molded in a two-step molding process, such as a double shot or overmolding process, as described above. In other embodiments, the body 202 and the ribs 218 can be formed separately and then attached to one another. In some embodiments, the ribs 218 comprise a thermoplastic elastomer (TPE), silicon rubber, high-density polyethylene (HDPE), polypropylene (PP), low-density polyethylene (LDPE), polyamides, polychlorotrifluoroethylene, various thermoplastics, and/or various elastomers. In some embodiments, the ribs 218 comprise a food grade TPE or thermoplastic polyurethane (TPU). The composition of the ribs 218 is not limited to the above materials, but can be selected for specific characteristics including the ability to clean on and around teeth. In some embodiments, the ribs 218 may comprise a material with a Shore A hardness of between 70 and 100, between 75 and 95, or between 80 and 90, or between 85 and 90. Shore A hardnesses within these ranges can provide the comfort and efficiency advantages discussed above.

In the illustrated embodiment, the oral hygiene device 200 includes ribs 218 positioned both in the channel 216 and extending from the bottom wall 224 of the body 202 so that the ribs 218 can contact the user's upper and lower teeth at the same time. Such an embodiment can advantageously reduce the total time required to freshen the mouth or clean the teeth be cleaning both the top and bottom teeth simultaneously. In some embodiments, the oral hygiene device 200 may include ribs 218 on only one side of the body 202 (e.g., the upper side or the lower side).

In some embodiments, the shape of the ribs 218 can be formed in order to contour to a user's mouth and teeth. In some embodiments, the ribs 218 are about 1.2 mm, 1.0 mm, 0.8 mm, 0.6 mm, or 0.5 mm thick, although other thicknesses, both thinner and thicker than these example values are possible. The thickness can be selected to facilitate teeth cleaning efficiency.

In some embodiments, the size and shape of the ribs 218 varies depending upon the location of the ribs 218 on the body 202. For example, the size and shape of the ribs 218 can be adjusted to suit the general size and shape of the particular teeth the ribs 218 will generally overlie when the oral hygiene device 200 is positioned within the mouth. Ribs 218 that are positioned on the body 202 to generally overlie molars (which are generally thicker) may have a different shape than ribs 218 that are positioned to overlie incisors (which are generally thinner). The ribs 218 can also be configured such that they contact more than one surface of the user's teeth at a time. For example, the ribs 218 can be configured to contact the front, bottom and back surfaces of the user's upper teeth and/or the front, top, and back surfaces of the user's teeth simultaneously.

The ribs 218 may also have a shape that is adapted to clean the user's gums and/or gum line. For example, the ribs 218 may be angled with respect to the gums so as to clean the space between the gums and the teeth. In some examples, the ribs 218 are configured to contact the gums at an angle between 30 and 60 degrees, between 40 and 50 degrees, or approximately 45 degrees, as discussed below with reference to the fingers 226 of the ridges.

In the illustrated embodiment, the oral hygiene device 200 includes ribs 218 positioned within the channel 216. The ribs 218 positioned within the channel 216 can be configured to clean the upper teeth of the user. As illustrated, ribs 218 extend generally across the channel 216 from the inner wall 220 to the outer wall 222, as well as along the inner surfaces of the inner wall 220 and the outer wall 222. Such a configuration can allow the ribs to contact multiple surfaces of the user's teeth simultaneously as described above.

In the illustrated embodiment, the oral hygiene device 200 includes about 33 ribs in the channel 216, although other numbers are possible (e.g., about 15, about 20, about 25, about 30, about 35, about 40, about 45, or about 50 ribs 218). The ribs 218 may be spaced evenly or unevenly. In some embodiments, the ribs 218 are spaced apart so as to be aligned with the spaces between the user's teeth or the interproximal contact area (IPC) when the oral hygiene device 200 is inserted into the mouth. In some embodiments, there can be more ribs 218 disposed in the channel 216 than there are upper teeth. This can provide additional coverage for teeth cleaning and can reduce the amount a user would need to move the oral hygiene device 200 in order to contact and adequately clean all the teeth. In some embodiments, the ribs 218 are spaced about 2 mm, 4 mm, 6 mm, 8 mm, or 10 mm apart, although other spacings are possible. The position and spacing of the ribs 218 can be selected to facilitate operation of the device. For example, the ribs 218 can be positioned so as to efficiently clean the teeth. In some embodiments, the oral hygiene device 200 can have different sizes to accommodate different mouth sizes. For example, in some embodiments, the oral hygiene device 200 can be adapted for use in a child's mouth. In this case, the oral hygiene device 200 can include fewer ribs 218 and/or different rib spacing, based on a child's mouth's dimensions and/or number of teeth. In some embodiments, the oral hygiene device 200 can be adapted for use in an adult's mouth. In some embodiments, the spacing of the ribs 218 is a function of the average dimensions of each tooth.

In some embodiments, the shape of the individual ribs 218 may be varied to suit the particular teeth the ribs will contact during use. For example, as illustrated, the ribs 218 positioned within the back parts of the channel 216 (i.e., the ribs configured to clean molars) can have a wider cutout shape configured to match the thickness of the molars, and the ribs 218 positioned within the front part of the channel 216 (i.e., the ribs configured to contact incisors) have a narrower cutout shape configured to match the thickness of the incisors). In some embodiments, the shape of the ribs 218 positioned within the channel 216 is configured to contact the front surface, bottom surface, and back surface of the user's upper teeth

As shown in FIGS. 2A, 2C, and 2D, one or more of the ribs 218 positioned within the channel 216 may include a finger 226. The finger 226 be configured as a protrusion or extension that extends from the ribs 218. In some embodiments, the finger 226 can be configured to clean the gum line. In some embodiments, the finger 226 is angled at an angle of between 30 and 60 degrees, between 40 and 50 degrees, or approximately 45 degrees with respect to the bottom wall 224, although other angles are also possible. The angle of the fingers 226 can be set in order to provide an optimal cleaning angle when the finger 226 contacts the teeth and/or the gum line. In some embodiments, the cleaning angle varies depending upon the location within the mouth. For example, the angle at the front teeth may differ from the angle at the back teeth. In some embodiments, fingers 226 can also be included to clean the inner gum line and/or to clean the inner or outer gum line on the upper and/or lower teeth. The bass technique is a common conventional toothbrush technique for preventing and controlling gum disease by brushing around and under the gum line where bacteria and plaque tend to accumulate. Using the bass technique, a user places the toothbrush parallel to his or her teeth with the bristles toward the gums and then tilts the brush to a 45-degree angle to position the bristles slightly under the gum line. The fingers 226 of the ribs 216 can be configured at a 45-degree angle so as to provide similar benefits as the bass technique. The fingers 226 can, for example, be configured to clean the gum line.

The ribs 218 positioned within the channel 216 may be connected by a spline 229 as shown. The spline 229 can be configured to clean the occlusal surface of the teeth. The spline 229 can be positioned within the channel 216 on the bottom wall 224. In some embodiments, the spline 229 runs continuously from one end of the channel 216 to the other. The shape, size, materials, and placement of the spline 229 can be based on specific desirable characteristics, such as the ability to clean the occlusal surface of each tooth. In some embodiments, the spline 229 is broken at various points along its length to comprise various discrete sections. For example, as best seen in FIG. 2E, the spline 229 can include at least three sections as shown. These three sections may facilitate a dual-hinged design, as shown, for example, in FIGS. 3A-4B, described below.

Opposite the channel 216, the oral hygiene device 200 also includes ribs 218 extending outwardly (e.g., downwardly) from the bottom wall 224. These ribs 218 can be configured to clean the user's bottom teeth. As illustrated, the ribs 218 extend generally across the bottom wall 224 form the inner wall 220 to the outer wall 222, although this need not be the case in all embodiments. In the illustrated embodiment, the oral hygiene device 200 includes 16 ribs extending from the bottom wall 224 opposite the channel 216, although other numbers are possible (e.g., about 10, about 20, about 25, about 30). As with the ribs 218 positioned within the channel 216, the ribs 218 positioned opposite the channel 216 may be spaced evenly or unevenly. The spacing or number of the ribs 218 positioned within the channel 216 need not match the spacing or number of the lower ribs 218 positioned opposite the channel 216. In some embodiments, the spacing of the lower ribs 218 is greater than the spacing of the upper ribs 218 (for example, as shown). In some embodiments, the number of lower ribs 218 is less than the number of upper ribs 218. In some embodiments, the ribs 218 positioned opposite the channel are about 2 mm, 4 mm, 6 mm, 8 mm, 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, or 20 mm apart, although other spacings are possible.

As noted previously, the shape of the individual ribs 218 may be varied to suit the particular teeth the ribs 218 will generally overlie during use. This may also be true for the lower ribs 218. For example, the ribs 218 positioned within the back parts of device 200 (i.e., the ribs configured to overlie the lower molars) can include a wider cutout shape configured to match the thickness of the molars, and the ribs 218 positioned on the front part of the device 200 (i.e., the ribs configured to overlie the front incisors) can include a narrower cutout shape configured to match the thickness of the incisors). In some embodiments, the shape of the lower ribs 218 extending from the bottom wall 224 are configured to contact the front surface, top surface, and back surface of the user's lower teeth.

As best seen in FIGS. 2B, 2F, and 2G, the lower ribs 218 may comprise a general T-shape, each having a flange 228 that extends generally aligned with and parallel to the outer wall 222. In some embodiments, the flange 228 provides structural support for the lower ribs 218. In some embodiments, the flange 228 may not contact the teeth during use. The size of the flange 228 can be reduced from the size illustrated in the figures.

As shown in FIGS. 2B and 2G, the front most lower ribs 218 can include an angled finger 230 formed on the inner most side of the ribs 218. The finger 230 may be configured to clean the back side of the lower front teeth and/or the gum line along the back of the lower front teeth. In the illustrated embodiment, the four front-most lower ribs 218 include fingers 230. In other embodiments, other numbers of the lower ribs 218 can include the finger 230 (for example, one, two, three, four, five, six, or more of the lower ribs 218 can include the finger 230). Others of the lower ribs 218 (for example, the ribs 218 configured to be positioned over lower molars) can include an increased height on the outer edge of the ribs 218 and a decreased height on the inner edge of the ribs 218.

FIGS. 3A and 3B are top views of an embodiment of an oral hygiene device 400 that includes dual hinges 402. The dual hinges 402 allow the oral hygiene device 400 to transition between an open configuration (as shown in FIG. 3A) and a closed configuration (as shown in FIG. 3B). As shown in FIG. 3A, in the open configuration, the dual hinges 402 allow the device to transition from a U-shape (for example, as shown in FIGS. 1A-1B and 2A-2G) to a more linear shape that extends generally along an axis 410. This may be advantageous as it may allow the oral hygiene device 400 to be packaged in longer and thinner packages (see FIGS. 5A-5C described below) which may be more space efficient and easier to carry. As shown in FIG. 3B, in the closed configuration, the dual hinges 402 allow the oral hygiene device 400 to transition to a U-shape configured to match the shape of the user's mouth and teeth.

In the illustrated embodiment, the body of the oral hygiene device 400 is divided into three sections: a front section 411, and two rear sections 413. The sections can be formed by manufacturing or cutting the body of the oral hygiene device 400 with an angle 436 as shown in FIG. 3A. In some embodiments, the body is molded as a single piece (e.g., with a single shot or double shot injection molding process as described above), which includes the three sections in an open configuration as shown in FIG. 3A. In some embodiments, the angle 436 is between 60 and 140 degrees. In one embodiment, the angle 436 is about 80 degrees. In another embodiment, the angle is about 120 degrees. One of skill in the art will appreciate that the angle 436 may be varied to control the overall thickness of the product in the open configuration. For example, an angle 436 of about 120 degrees may allow the device 400 to fit into a thinner container in the open configuration than an angle of about 80 degrees.

In the illustrated embodiment, the oral hygiene device 400 includes two hinges 402. The hinges 402 connect each rear section 413 to one side of the front section 411. The hinges 402 may be positioned on the outer wall 422 of the oral hygiene device 400. In some embodiments, the hinges 402 are living hinges. In some embodiments, the hinges 402 are mechanical hinges. The hinges 402 can be integrally molded with the body 402.

Opposite the hinges 402, the oral hygiene device 400 may include locking mechanisms 404. The locking mechanisms 404 can be integrally molded with the body. The locking mechanisms 404, can be configured to secure the shape of the oral hygiene device 400 in the closed configuration. Various types of locking mechanisms are possible. For example, as illustrated, each locking mechanism comprises a latching member 406 and a catching member 408. To secure the locking mechanism 404, the latching member 406 engages with the catching member 408. Other types of locking mechanisms 404 are possible. The locking mechanism 404 can be selected for specific characteristics including ease of use, efficiency of locking, and small size.

FIGS. 4A and 4B are detail views of an embodiment of the locking mechanism 404. FIG. 4A illustrates the locking mechanism 404 just prior to locking into place, and FIG. 4B illustrates the locking mechanism 404 locked into place. As shown in FIG. 4A, prior to locking, the latching member 406 can contact (without lockingly engaging) the catching member 408. To lockingly engage, the locking member 406 must deflect outwardly to allow a hooked end of the locking member 406 to pass the catching member 408. Once the hooked end passes the catching member 408 it falls back behind it, locking the locking mechanism 404 in place.

In some embodiments, the user can release the locking mechanisms 404 to return the oral hygiene device 400 to the open configuration. In some embodiments, once locked, the locking mechanisms 404 remain locked (i.e., one time use).

Returning to FIGS. 3A and 3B, in some embodiments, the rear most portions 412 of the oral hygiene device 400 can be made from a soft material to improve the comfort of the device. For example, in some embodiments, the rearmost portions 412 of the bottom wall (and/or side walls) are made of the same material as the ribs, rather than the same material as the body. As the user manipulates the device to clean the teeth, the rearmost portions 412 may contact the user's mouth and using a softer material in these areas may improve the experience.

The features illustrated with respect to FIGS. 3A-4B can be included on any of the other oral hygiene devices described herein. For example, the oral hygiene device 700 of FIGS. 7A-7K can include a hinged design similar to the oral hygiene device 400.

FIGS. 5A-5C show example containers or packages 500 for oral hygiene devices. FIG. 5A is a perspective view of an embodiment of a container 500 for an oral hygiene device. In this embodiment, the container 500 comprises an elongated wrapper, similar to a candy wrapper. The container 500 can be configured to enclose an oral hygiene device that is in an open, elongated configuration, for example as shown in FIG. 3A. FIG. 5B is a front view of the container 500 of FIG. 5A and illustrates how the oral hygiene device 400 of FIGS. 3A-4B may fit within the container 500, for example.

FIG. 5C is a perspective view of another embodiment of a container 500 for an oral hygiene device. In this embodiment, the container 500 comprises an elongated tube. The elongated tube may include a cap. Again, similar to the container shown in FIGS. 5A-5B, the container 500 of FIG. 5C can be configured to enclose an oral hygiene device 400 that is in an open, elongated configuration, for example as shown in FIG. 3A. The materials of the containers or packages are selected for specific characteristics, including ability to withstand friction and force, such as in a purse, briefcase, or suitcase.

In other embodiments, various containers can be provided that are configured to enclose oral hygiene devices in their closed or U-shaped configurations.

As mentioned previously, in some embodiments, the oral hygiene devices described herein are configured to be portable and/or disposable. Those of ordinary skill in the art, upon consideration of this disclosure, will appreciate that the size, shape, and type of container selected to facilitate carrying the oral hygiene device in a space efficient manner suitable for a pocket or bag.

FIGS. 6A-6D illustrate views of an embodiment of an oral hygiene device 600 that includes beads 640 of mouthwash, breath freshener, toothpaste, desensitizing paste or gel, or whitening paste or gel. FIG. 6A is a top perspective view and FIG. 6B is a bottom perspective view. In the illustrated embodiment, the oral hygiene device 600 also includes the hinged design described above. FIG. 6C illustrates the oral hygiene device 600 in an open configuration, and FIG. 6D illustrates the device in a closed configuration.

In the illustrated embodiment, five beads 640 of mouthwash, breath freshener, toothpaste, desensitizing paste or gel, or whitening paste or gel are shown, but other numbers of beads 640, as well as other positions for the beads 640, are possible. In some embodiments, the beads 640 comprise are referred to as “dabs.” As mentioned previously, in some embodiments, the oral hygiene devices described herein are configured to be useable without water or toothpaste, as such the beads 640 of mouthwash, breath freshener, toothpaste, desensitizing paste or gel, or whitening paste or gel can be configured to also be useable without requiring water and/or without requiring the user to rinse out his or her mouth after use. Alternatively, in some embodiments, the beads 640 can comprise beads of a dentifrice that can be used with water during use of the device. The size, shape, materials, and location of the beads is selected for specific characteristics including the ability to freshen breath or clean the mouth.

In some embodiments, the beads 640 are positioned within pockets or indentations formed on the device 600. For example, as best seen in FIGS. 6C and 6D, the beads 640 can be positioned within pockets that are formed of the same material as the ribs of the device 600. These pockets can be formed with the device 600 as the device is molded. The beads 640 can then be applied to the pockets later during manufacturing. Alternatively, the pockets can be formed as part of the body of the device.

In the illustrated embodiment of FIGS. 6A-6D, the beads 640 are positioned on the upper portion of the device. In some embodiments, no beads 640 are positioned on the lower power of the device. In some embodiments, beads 640 are positioned on both the upper and lower portions of the device. In some embodiments, an upper portion of the device may include a different number of beads 640 than a lower portion of the device.

In some embodiments, the beads 640 of mouthwash, breath freshener, toothpaste, desensitizing paste or gel, or whitening paste or gel are positioned on the oral hygiene device so as to be automatically activated when the oral hygiene device is used by the user. In some embodiments, the beads 640 are activated by biting, grinding, or crushing by the user's teeth during use of the oral hygiene device 600. In some embodiments, the beads 640 dissolve into the mouth during use.

In some embodiments, the beads or dabs 640 can comprise a formulation configured to clean and freshen one's mouth, and that can be used without water. In some embodiments, the beads or dabs 640 comprise a formulation that is safe to be swallowed. This can allow a user to quickly and easily use the oral hygiene devices anywhere. In other embodiments, the beads or dabs 640 can comprise formulations that are not safe to be swallowed (such as formulations that include fluoride or mouthwash). Several example formulations are shown in the following tables.

Sample Formulation 1 Ingredient % w/w g/batch Function Xanthan Gum 0.500 0.500 Viscosity Builder Poloxamer P407 30.000 30.000 Gelling Agent Glycerin 10.000 10.000 Humectant Xylitol 10.000 10.000 sweetener SLS 1.500 1.500 Foaming FD&C Blue 2 0.050 0.050 Color Mint 2.000 2.000 Flavor Water 45.950 45.950 Solvent

Sample Formulation 2 Ingredient % w/w g/batch Function Xanthan Gum 0.500 0.500 Viscosity Builder Poloxamer P407 25.000 25.000 Gelling Agent Glycerin 10.000 10.000 Humectant Xylitol 10.000 10.000 sweetener SLS 1.500 1.500 Foaming FD&C Blue 2 0.050 0.050 Color Mint 1.000 1.000 Flavor Water 51.950 51.950 Solvent

Sample Formulation 3 Ingredient % w/w g/batch Function Xanthan Gum 0.500 0.500 Viscosity Builder Poloxamer P407 25.000 25.000 Gelling Agent Glycerin 10.000 10.000 Humectant Sucralose 0.125 0.125 sweetener SLS 1.500 1.500 Foaming FD&C Blue 2 0.050 0.050 Color Mint 1.500 1.500 Flavor Water 61.325 61.325 Solvent

Sample Formulation 4 Ingredient % w/w g/batch Function Xanthan Gum 0.750 0.750 Viscosity Builder Poloxamer P407 20.000 20.000 Gelling Agent Glycerin 10.000 10.000 Humectant Sucralose 0.125 0.125 sweetener SLS 1.000 1.000 Foaming FD&C Blue 2 0.050 0.050 Color Mint 1.500 1.500 Flavor Water 66.575 66.575 Solvent

Sample Formulation 5 Ingredient % w/w g/batch Function Xanthan Gum 1.000 1.000 Viscosity Builder Poloxamer P407 15.000 15.000 Gelling Agent Glycerin 10.000 10.000 Humectant Sucralose 0.125 0.125 sweetener SLS 1.000 1.000 Foaming FD&C Blue 2 0.050 0.050 Color Mint 1.500 1.500 Flavor Water 71.325 71.325 Solvent

Sample Formulation 6 Ingredient % w/w g/batch Function Xanthan Gum 1.000 1.000 Viscosity Builder Poloxamer P407 18.000 18.000 Gelling Agent Glycerin 10.000 10.000 Humectant Sucralose 0.125 0.125 sweetener SLS 0.500 0.500 Foaming FD&C Blue 2 0.050 0.050 Color Mint 1.500 1.500 Flavor Water 68.825 68.825 Solvent

Sample Formulation 7 Ingredient % w/w g/batch Function Xanthan Gum 1.000 1.000 Viscosity Builder Poloxamer P407 18.000 18.000 Gelling Agent Glycerin 10.000 10.000 Humectant Sucralose 0.125 0.125 sweetener SLS 0.500 0.500 Foaming Green DB-110004 0.005 0.005 Color - Dye Blend Mint 1.500 1.500 Flavor Water 68.870 68.870 Solvent

Sample Formulation 8 Ingredient % w/w g/batch Function Xanthan Gum 1.000 1.000 Viscosity Builder Poloxamer P407 18.000 18.000 Gelling Agent Glycerin 10.000 10.000 Humectant Sucralose 0.125 0.125 Sweetener SLS 0.500 0.500 Foaming Green DB-110004 0.005 0.005 Color - Dye Blend Menthol 0.500 0.500 Flavor Water 69.870 69.870 Solvent

Sample Formulation 9 Function Ingredient % w/w g/batch Viscosity Builder Xanthan Gum 1.000 1.000 Gelling Agent Poloxamer P407 18.000 18.000 Humectant Glycerin 10.000 10.000 sweetener Sucralose 0.125 0.125 Foaming SLS 0.500 0.500 Color - Dye Blend Green DB-110004 0.005 0.005 Flavor Menthol 0.750 0.750 Solvent Water 69.620 69.620

While any of the above-listed sample formulations are useable in the beads or dabs 640, testing has revealed that sample formulation 8 and sample formulation 9, which include menthol as a flavorant at 0.50% w/w and 0.75% w/w, respectively, are potent, and can provide a strong burst of freshener, which can be desirable.

Although the beads 640 are depicted in the oral hygiene device 600, a person of skill in the art, guided by this disclosure, would understand that the beads 640 can be incorporated into any of the various embodiments of the oral hygiene device described herein. For example, the oral hygiene device 700 of FIGS. 7A-7K is also configured with beads, which are described in more detail below. As will be described below, the beads 640 may also comprise fluoride, iodine, or chlorohexidine, among other things. In some embodiments, the mouth wash or breath freshener can be applied to the device as a strip, rather than discrete beads. This may facilitate application on an assembly line by an automated process.

FIGS. 7A-7K illustrate views of another embodiment of an oral hygiene device 700. In some respects, the oral hygiene device 700 is similar to the oral hygiene device 100 b shown in FIG. 1B, because the oral hygiene device 700 of FIGS. 7A-7I may similarly be configured for cleaning only the user's upper teeth or the user's lower teeth at a time. The oral hygiene device 700 can be used, for example, to clean the user's upper teeth and then can be flipped over and used to clean the user's lower teeth, or vice versa. FIG. 7A is a top and side perspective view, FIG. 7B is a bottom and side perspective view, FIG. 7C is a top and front perspective view, FIG. 7D is a side view, FIG. 7E is a top view, FIG. 7F is a bottom view, FIG. 7G is a first cross-sectional view, and FIG. 7G is a second cross-sectional view of the oral hygiene device 700. FIG. 7I illustrates a perspective view of the body 702 of the oral hygiene device 700. FIGS. 7J and 7K are back and front view so of the device 700.

With reference to FIGS. 7A-7I, the oral hygiene device 700 includes a body 702. The body 702 is shown alone in FIG. 7I and in FIGS. 7A-7H with additional teeth cleaning features molded there on. In the illustrated embodiment, the body 702 is generally U-shaped similar to the oral hygiene devices described previously. For example, the generally U-shaped body 702 can be configured to generally follow the shape of a user's upper and/or lower teeth. As illustrated, the body 702 also includes a generally U-shaped cross-sectional profile, similar to the oral hygiene devices 100 b, 200 (and others) described above. The generally U-shaped cross-sectional profile may include an inner wall 720, an outer wall 722, and a bottom wall 724 as shown. The generally U-shaped cross-sectional profile can define a channel 716 within the body 702. The channel 716 can be formed between the inner wall 720 and the outer wall 722 and bounded below by the bottom wall 724. In some embodiments, the body 702 can be configured in size and shape such that the channel 716 is configured to receive the user's upper teeth or lower teeth during use of the oral hygiene device 700.

As shown in the cross-sectional views of FIGS. 7G and 7H, the shape of the channel 716 may vary at different positions of the body 702. For example, as shown in FIG. 7G, at the front of the body 702, the inner wall 720 may be formed at an angle with respect to the bottom wall 724. In some embodiments, the angle is between 30 and 60 degrees, between 40 and 50 degrees, or about 45 degrees. As shown, the outer wall 722 can extend at a substantially 90-degree angle (for example, 90 degrees plus or minus 5 or 10 degrees) with respect to the bottom wall 724. This shape allows the body 702 to fit comfortably over the user's front teeth, which generally comprises substantially vertical front surfaces and sloping, angled rear surfaces.

FIG. 7H is a cross-sectional view of the oral hygiene device 700 taken through a rear portion of the device. As shown, at this position, both of the inner and outer walls 720, 724 are positioned at a substantially 90-degree angle (for example, 90 degrees plus or minus 5 or 10 degrees) with respect to the bottom wall 724. This shape can facilitate a good fit over the user's back teeth (e.g., molars), which are generally more rectangular in shape. Comparing FIGS. 7G and 7H, one can also see that, in the illustrated embodiment, the width of channel 716 can narrow from the rear of channel (FIG. 7H) toward the front of the channel (FIG. 7G). Again, this shape can facilitate fit with the user's teeth.

An additional feature that can facilitate good fit for the device 700 is visible in FIGS. 7G and 7H. As shown, the inner wall 720 can be shorter than the outer wall 722. This shape may be beneficial due to the anatomy of the mouth due to the upper palate, lower jaw, and tongue. In some instances, users may experience pain or discomfort if the inner wall 720 and the outer wall 722 are the same height or if the inner wall 720 is too tall. Accordingly, in some embodiments, the inner wall 720 is less than 10 mm, less than 8 mm, less than 6 mm, less than 5 mm, or less than 4 mm tall. In some embodiments, the heights of inner wall 720 and the outer wall 722 can increase from the back towards the front of the body 702.

The body 702 may be made of a rigid, semi-rigid, or flexible material, such as plastic, rubber, a polymer, or other suitable material. In some embodiments, the body 702 is rigid enough to provide general support and shape for the oral hygiene device 700, while remaining flexible enough to allow the body 702 to fit to the particular anatomy of the user's mouth and teeth. In some embodiments, the body 702 comprises a thermoplastic elastomer (TPE), high-density polyethylene (HDPE), polypropylene (PP), low-density polyethylene (LDPE), polyamides, polyolefin or other resins, polychloro-trifluoroethylene, various thermoplastics, and/or various elastomers. In some embodiments, the body 702 may comprise a food grade polypropylene. The composition of the body 702 is not limited to the above materials, but is selected for specific characteristics including enough rigidity to provide general support and shape for the oral hygiene device 700, while including enough flexibility to allow the body 202 to fit to the particular anatomy of the user's mouth and teeth.

The body 702 may be formed such that the walls (e.g., the inner wall 720, the outer wall 722, and the bottom wall 724) are sufficiently thin so as to allow the body 702 to flex and conform to the shape of the user's mouth. For example, in some embodiments, the walls of the body 202 are about 2 mm, 1.5 mm, 1.0 mm, 0.75 mm, 0.5, or 0.25 mm thick. In some embodiments, the nominal thickness of the walls of the body 702 is about 1.2 mm. These thicknesses are provided by way of example, and the thickness of the walls of the body 702 can be selected to provide the desired characteristics described throughout this application.

FIG. 7I illustrates the body 702 alone. As shown in FIG. 7I, the body 702 can include a number of features formed within the channel 716 on the inner surfaces of the inner wall 720, the outer wall 720, and the bottom wall 724. As illustrated, the body 702 includes a plurality of grooves 711 formed within the channel. As illustrated, the grooves 711 can extend up and down the inner and outer walls 720 and along the bottom wall 724. The grooves 711 can be configured to receive the teeth cleaning features of the oral hygiene device 700, such as the ribs 718 described below. As such, the spacing of the grooves can be configured to match the spacing of the ribs 718 as will be described below. In some embodiments, for example, as illustrated, the body 702 may also comprise an indention 713 that extends along the inner surface of the bottom wall 724 as shown. The indention 713 can be configured to receive the spline 729, which is described below. FIG. 7I also illustrates that one or more apertures 715 can be formed through the bottom wall 724. As will be described below the apertures 715 can be configured to receive wells for holding beads or dabs of cleaning and/or freshening material.

In some embodiments, the oral hygiene device 700 can be provided in a variety of sizes (e.g., small, medium, large, adult, or child) configured for use by users that have different size mouths. In some embodiments, the oral hygiene device 700 can be provided in a size that is generally configured to fit most mouth sizes. For example, in some embodiments, the device 700 may comprise a width configured to fit mouths with a molar to molar width of about 50 mm to 65 mm, about 50 mm to 62 mm, about 52 mm to 58 mm, or about 54 mm to 56 mm. The device 700 may comprise a length configured to fit mouths with a front tooth to rear molar length of between 40 mm and 55 mm, between 40 and 50 mm, or between 43 and 49 mm. In some embodiments, the width of the device 700 is at least 62 mm. Measurements of many mouths were taken between the buccal of the second molar on the right and the buccal of the second molar of the left of the upper teeth. 62 mm was determined to be widest measurement.

As illustrated, the oral hygiene device 700 includes a handle 710. The handle 710 can be configured as a tab, although other shapes are possible as described in greater detail below (see, for example, FIGS. 17A-17D). The handle 710 can extend from a front portion of the body 702 so as to be able to extend out of the user's mouth between the user's lips when the oral hygiene device 700 is inserted into the user's mouth. In the illustrated embodiment, the handle 710 extends form the outer wall 722 of the body 702 at a position between the bottom wall 724 and the top of the outer wall 722. Alternatively, the handle 710 may be aligned with the bottom wall 724 of the body 702, or the handle 710 can be placed in any other desired location. In some embodiments, the oral hygiene device 700 does not include a handle 710 (i.e., the handle 710 may be omitted). Similar to the discussion above, the user may use the handle to manipulate the oral hygiene device 700 to use the oral hygiene device 700 to clean the user's teeth. In some embodiments, the handle 710 comprises a length of 11 mm and a width of 22 mm. However, other shapes of the handle 710 are also possible. For example, a longer handle 710 could be used that extends further out of the mouth. This may provide an easier hold for people with dexterity problems. This may also provide easier access to a caregiver using the device 700 on another person. For example, the caregiver may not have to put their fingers into the person's mouth.

Similar to the oral hygiene devices 100 a, 100 b, 200 (and others) described generally above, the oral hygiene device 700 can include teeth cleaning features configured to clean the user's teeth when the device is used. In the illustrated embodiment, the teeth cleaning features comprise the ribs 718, although in other embodiments, other types of teeth cleaning features (e.g., foam, bristles, textured surfaces, etc.) can be used in addition to or in place of the ribs 718.

The ribs 718 can be formed of the same material as the body 702, or the ribs 718 can be formed of a softer or more flexible material than the body 702 as described above. Advantageously, forming the body 702 and the ribs 718 of different materials may improve functionality, comfort, and efficiency of the device. For example, as described above the body 702 can be formed of a generally stiffer and more rigid material to provide structural support for the device 700, while the ribs 718 can be formed of a generally less rigid or softer material. The softer material of the ribs 718 can provide more user comfort during use, while also better conforming to the user's mouth and teeth shape to provide increased cleaning efficiency.

The ribs 718 can be integrally formed with the body 702 or can be separately formed and attached to the body 702. In some embodiments, the body 702 and ribs 718 are co-molded in a two-step molding process, such as a double shot or overmolding process, as described above. In other embodiments, the body 702 and the ribs 718 can be formed separately and then attached to one another. In some embodiments, the ribs 718 comprise a thermoplastic elastomer (TPE), silicon rubber, high-density polyethylene (HDPE), polypropylene (PP), low-density polyethylene (LDPE), polyamides, polychlorotrifluoroethylene, various thermoplastics, and/or various elastomers. In some embodiments, the ribs 718 comprise a food grade TPE or thermoplastic polyurethane (TPU). The composition of the ribs 718 is not limited to the above materials, but can be selected for specific characteristics including the ability to clean on and around teeth. In some embodiments, the ribs 718 may comprise a material with a Shore A hardness of between 70 and 100, between 75 and 95, or between 80 and 90, or between 85 and 90. Shore A hardnesses within these ranges can provide the comfort and efficiency advantages discussed above.

In the illustrated embodiment, the ribs 718 are positioned within the channel 716. In some embodiments, the shape of the ribs 718 can be formed in order to contour to a user's mouth and teeth. In some embodiments, the ribs 718 are about 1.2 mm, 1.0 mm, 0.8 mm, 0.6 mm, or 0.5 mm thick, although other thicknesses, both thinner and thicker than these example values are possible. The thickness can be selected to facilitate teeth cleaning efficiency and/or user comfort.

In some embodiments, the size and shape of the ribs 718 varies depending upon the location of the ribs 718 on the body 702. For example, the size and shape of the ribs 718 can be adjusted to suit the general size and shape of the particular teeth the ribs 718 will generally overlie when the oral hygiene device 700 is positioned within the mouth. Ribs 718 that are positioned on the body 702 to generally overlie molars (which are generally wider) may have a different shape than ribs 718 that are positioned to overlie incisors (which are generally thinner). The ribs 718 can also be configured such that they contact more than one surface of the user's teeth at a time. For example, the ribs 718 can be configured to contact the front, bottom and back surfaces of the user's upper teeth and/or the front, top, and back surfaces of the user's teeth simultaneously.

These features can be seen, for example, in the cross-sectional views of FIGS. 7H and 7G. As noted above, FIGS. 7G and 7H illustrate that the cross-sectional shape of the body 702 can vary from the back to the front of the device 700. As the ribs 718 are formed on the body 702, the shape of the ribs 718 can also vary from the back to the front. For example, as shown in FIG. 7G, the inner portion of the ribs 718 at the front of the device can be formed at an angle with respect to the bottom wall 724. In some embodiments, the angle is between 30 and 60 degrees, between 40 and 50 degrees, or about 45 degrees. As shown, an outer portion of the ribs 718 at the front of the device can extend at a substantially 90-degree angle (for example, 90 degrees plus or minus 5 or 10 degrees) with respect to the bottom wall 724. This shape can follow the shape of the channel 716 as described above and facilitate fit and user comfort. As shown in FIG. 7H, both the inner and outer portions of the ribs 718 at the rear of the device 700 can extend at a substantially 90-degree angle (for example, 90 degrees plus or minus 5 or 10 degrees) with respect to the bottom wall 724. Again, this shape follows the shape of the channel 716 and can provide good fit and comfort.

The ribs 718 may also have a shape that is adapted to clean the user's teeth, gums, and/or gum line. In the illustrated embodiment, the oral hygiene device 700 includes ribs 718 positioned within the channel 716. The ribs 718 positioned within the channel 716 can be configured to clean the upper and/or lower teeth of the user depending upon the orientation of the device 700. As illustrated, ribs 718 extend generally across the channel 716 from the inner wall 720 to the outer wall 722, as well as along the inner surfaces of the inner wall 720 and the outer wall 722. Such a configuration can allow the ribs to contact multiple surfaces of the user's teeth simultaneously as described above. In some embodiments, the shape of the individual ribs 718 may be varied to suit the particular teeth the ribs will contact during use. For example, as illustrated, the ribs 718 positioned within the back parts of the channel 716 (i.e., the ribs configured to clean molars) can have a wider cutout shape configured to match the thickness of the molars, and the ribs 718 positioned within the front part of the channel 716 (i.e., the ribs configured to contact incisors) have a narrower cutout shape configured to match the thickness of the incisors).

The one or more of the ribs 718 can include fingers 726 extending therefrom. The fingers 726 may be angled with respect to the gums so as to clean the space between the gums and the teeth. The fingers 726 be configured as protrusions or extensions that extend from the ribs 718. In some embodiments, the fingers 726 can be configured to clean the gum line. In some embodiments, the fingers 726 can be angled inwardly at an angle of between 30 and 60 degrees, between 40 and 50 degrees, or approximately 45 degrees with respect to the bottom wall 724, although other angles are also possible. The angle of the fingers 726 can be set in order to provide an optimal cleaning angle when the finger 726 contacts the teeth and/or the gum line (for example, as discussed above with regards to the Bass technique).

In some embodiments, the ribs 718 can be smaller or omitted at the rear ends of the oral hygiene device 700. For example, as shown in FIG. 7A, the last four ribs 718 on each end of the device 700 do not include the fingers 726. Thus, in the illustrated embodiment, the last four ribs 718 on each ends are smaller than the remaining ribs 718 on the device. In some embodiments, the ribs on the last 10 mm, 9 mm, 8 mm, 7 mm, 6 mm, or 5 mm of the device 700 can be smaller or omitted as shown. This can facilitate fit of the device 700 in the user's mouth and improve user comfort.

Moreover, in some embodiments, the rear most portions of the device 700 can be made from the same material as the ribs 718. Thus, the rearmost portions can be softer than body 702. For example, comparing FIGS. 7A and 7B to FIG. 7I, one can see that the rear most portions of the device 700 can extend beyond the rear most portions of the body 702. This can facilitate user comfort and accommodate different size mouths.

In the illustrated embodiment, the oral hygiene device 700 includes about 35 ribs in the channel 716, although other numbers are possible (e.g., about 15, about 20, about 25, about 30, about 35, about 40, about 45, or about 50 ribs 718). The ribs 718 may be spaced evenly or unevenly. In some embodiments, the ribs 718 are spaced apart so as to be aligned with the spaces between the user's teeth or the interproximal contact area (IPC) when the oral hygiene device 700 is inserted into the mouth. In some embodiments, there can be more ribs 718 disposed in the channel 716 than there are upper teeth. This can provide additional coverage for teeth cleaning and can reduce the amount a user would need to move the oral hygiene device 700 in order to contact and adequately clean all the teeth. In some embodiments, the ribs 718 are spaced about 2 mm, 4 mm, 6 mm, 8 mm, or 10 mm apart, although other spacings are possible. The position and spacing of the ribs 718 can be selected to facilitate operation of the device. For example, the ribs 718 can be positioned so as to efficiently clean the teeth. In some embodiments, the spacing of the ribs 718 is a function of the average dimensions of each tooth.

The ribs 718 positioned within the channel 716 may be connected by a spline 729 as shown, for example, in FIG. 7E. The spline 729 can be configured to clean the occlusal surface of the teeth. The spline 729 can be positioned within the channel 716 on the bottom wall 724. In some embodiments, the spline 729 runs continuously from one end of the channel 716 to the other. The shape, size, materials, and placement of the spline 729 can be based on specific desirable characteristics, such as the ability to clean the occlusal surface of each tooth. The spline 729 may interconnect the ribs 718. The spline 729 can be formed from the same material as the ribs 718.

The oral hygiene device 700 may also include reservoirs 730 for holding beads or dabs of a cleaning or freshening material as described above. In the illustrated embodiment, the device 700 includes three reservoirs 730 that extend through the apertures 715 of the body 702. As shown, one reservoir 730 is positioned at the front of the device 700 and the remaining two reservoirs 730 are positioned toward the rear of the device 700. These positions for the reservoirs 730 may work well to release the material of the dabs or beads over the much or all of the user's mouth or teeth and provide good coverage. Other numbers of reservoirs 730 and other positions for the reservoirs 730 are also possible. The reservoirs 730 can be formed from the same material as the spline 729 and the ribs 718. As shown in the figures, in some embodiments, the reservoirs 730 extend above and below the bottom wall 724. This may facilitate release of the bead or dab material. For example, in some embodiments, the reservoirs 730 may extend at least 0.5 mm, at least 1.0 mm, or at least 1.5 mm above and/or below the body 702.

As illustrated, in some embodiments, the reservoirs 730 can include within them one or more openings that extend therethrough. The openings may facilitate release of the bead or dab material both above and below the device 700 during use. In the illustrated embodiment, the front reservoir 730 includes six openings, while the rear two reservoirs 730 can include five openings. The size and number of the openings through the reservoirs 730 can be configured to release of the bead or dab material.

As shown in FIGS. 7B and 7F, the device 700 can include tongue cleaning features formed on the bottom surface of the bottom wall 724. As illustrated, the tongue cleaning features can comprise ridges 732 that project slightly downward from the bottom wall 724. The ridges 732 can extend downwardly from the bottom wall 724 of the body 702. In some embodiments, the ridges 732 extend at least 0.25 mm, at least 0.5 mm, at least 0.75 mm, at least 1.0 mm, at least 1.25 mm, at least 1.5 mm, or at least 2.0 mm below the bottom wall 724 of the body 702. The ridges 732 can be configured to scrape and/or clean the user's tongue as will be described in more detail below. The ridges 732 can be formed of the same material as the ribs 718. Although the tongue cleaning features are illustrated as ridges 732 in FIGS. 7A-7H, other tongue cleaning features can also be used in other embodiments.

The oral hygiene device 700 can be configured to be used to clean and/or freshen a user's mouth, teeth, and tongue. An example method of use for the device 700 will now be described. In this example, the device 700 can be inserted into the user's mouth. The user may hold the device 700 using the handle 710. The device 700 can be inserted into the mouth such that the user upper or the user's lower teeth are positioned within the channel 716. For example, the user's upper teeth can be positioned within the channel 716. With the device 700 so positioned, the user may manipulate the device 700 to freshen the mouth. For example, the user may manipulate the device 700 by moving the device 700 side-to-side and back-and-forth. During this motion, the ribs 718 can contact and clean the surfaces of the user's teeth. At the same time the fingers 726 can contact and clean the user's gum line. The motion can produce similar effects as the Bass technique described above. Further, while using the device, the dab and bead material device can be naturally released, providing additional cleaning and/or freshening for the mouth.

In some embodiments, while cleaning the user's upper teeth, the teeth cleaning features (ridges 732) of the bottom wall 724 of the device 700 can clean the user's tongue. This can be accomplished by moving the ridges 732 across the surface of the user's tongue. Advantageously, the bead or dab material can be released from the reservoir 730 onto the user's tongue providing additional freshening.

After the user's upper teeth and tongue are cleaned, the user can flip the device 700, such that the user's lower teeth are received within the groove 716. The device can then be used in a similar manner to clean the user's lower teeth. In some embodiments, the user's lower teeth can be cleaned first, before cleaning the user's upper teeth.

FIG. 8 is a top view of an embodiment of a formable oral hygiene device 800 that is initially generally straight, but can be formed into a U-shape during use to fit to a user's teeth. In some embodiments, instead of including hinges as described above with reference to FIGS. 3A-4B, the formable oral hygiene device 800 can be provided. As shown in FIG. 8, the formable oral hygiene device 800 can include a body 800 that initially extends generally linearly along an axis 801. This shape may be advantageous for storage, for example, within a long slender container, as shown in FIGS. 5A-5C. As illustrated in FIG. 8, the body 802 of the device also includes a channel 816 (which can include teeth cleaning features) and can have an H-shaped cross-section (see FIG. 1A) or U-shaped cross-section (see FIG. 1B). In the illustrated embodiment, the formable oral hygiene device 800 includes a handle 810 as shown.

The body 802 can be made of a flexible material, or otherwise configured to bend or flex, so that the user can form the formable oral hygiene device 800 into a U-shape when inserting the device 800 into the user's mouth. The U-shape will conform the formable oral hygiene device 800 to the general shape of the user's mouth and teeth. The user may then use the formable oral hygiene device 800 in the manner previously described. FIGS. 8-13B illustrate several embodiments of formable oral hygiene devices.

FIGS. 9A and 9B illustrate views of another embodiment of a formable oral hygiene device 900. To accommodate bending formable oral hygiene device 900 from a generally linear shape (FIG. 9A) to a general U-shape (FIG. 9B), the device 900 includes an outer wall 922 formed by three discrete portions 922A, 922B. In the linear configuration, the two portions 922B contact each other and the portion 922A is positioned inside of the two portions 922B. As the device 900 is bent to the U-shaped configuration, the ends of the two portions 922B move apart, exposing the portion 922A. Thus, in the linear configuration, the outer wall comprises the two portions 922B, and in the U-shaped configuration, the outer wall comprises the portion 922A and the two portions 922B. This allows the outer wall to increase in length to accommodate the bend. In the U-shaped configuration, the outer wall will have a larger radius than the inner wall, and thus, in this embodiment, must have a longer length.

FIGS. 10A and 10B illustrate views of another embodiment of a formable oral hygiene device 1000. In this embodiment, the body of the formable oral hygiene device 1000 comprises a plurality of laminated layers. As shown, outermost layers can comprise a longer length than the innermost layers to accommodate the larger radius of the outer wall 1022 in the U-shaped configuration (FIG. 10B). Accordingly, in this embodiment, the outer wall 1022 may be formed of a longer layer and the inner wall 1020 may be formed of a shorter layer.

FIGS. 11A and 11B illustrate views of another embodiment of a formable oral hygiene device 1100. In this embodiment, the outer wall 1122 includes a corrugated portion 1126, which allows the length of the outer wall 1122 to increase as the device 1100 is bent to the U-shaped configuration. The length and shape of the outer wall 1122 (including the corrugated portion 1126) and the inner wall 1120 can be configured such that a thickness between the outer wall 1122 and the inner wall 1120 matches an approximate thickness of the teeth when the device 1100 is bent into the U-shaped configuration. For example, the thickness can be narrower in areas that fit incisors and wider in areas that fit molars.

FIGS. 12A-12C illustrate views of another embodiment of a formable oral hygiene device 1200. As mentioned above, in the U-shaped configuration, the outer wall 1222 comprises a longer length (because of the larger radius) than the inner wall 1220. To accommodate this, the formable oral hygiene device 1200 includes an inner wall 1220 that includes a plurality of dentils, teeth, or tabs 1276. The tabs can be positioned on the inner wall 1220 in an area of high flex. In the linear configuration, the tabs 1276 are separated by gaps. When bent into the U-shaped configurations, the gaps between the tabs 1276 close up as shown.

FIGS. 13A and 13B illustrate views of another embodiment of a formable oral hygiene device 1300. The formable oral hygiene device 1300 is in some respects similar to the formable oral hygiene device 1100 (FIGS. 11A and 11B) described above. For example, the formable oral hygiene device 1300 includes an outer surface 1322 with a corrugated portion 13726. However, the formable oral hygiene device 1300 also includes an inner surface 1320 with a corrugated portion 1327.

FIGS. 14A-14D illustrate various embodiments for handles that can be used to manipulate the oral hygiene devices described herein. The various handles illustrated in these figures can be included on any of the oral hygiene device described above. Other types of handles are also usable. In general, the handle allows the user to manipulate the device (e.g., move the device back and forth and/or up and down) to clean the user's teeth.

FIG. 14A is a perspective view illustrating an embodiment of a handle 810A for an oral hygiene device 1400 a. In the illustrated embodiment, the handle 1410 a is a tab positioned on the front of the device as previously described.

FIG. 14B is a perspective view illustrating an embodiment of an oral hygiene device 1400 b that includes two handles 1410B. Each handle 1410B can be positioned on an opposite side of the device 1400 b. In some embodiments, the user uses a handle 1410B on one side to focus on cleaning the teeth on the corresponding side and then transitions to using the other handle 1410B on the other side to focus on cleaning the teeth on the other side.

FIG. 14C is a perspective view illustrating an embodiment of an oral hygiene device 1400 c that includes a contact point 1410C configured for manipulation of the device. In this embodiment, rather than including a handle, the device 1400 c includes a contact point 1410C that the user contacts to manipulate the device. The contact point 1410C may include a high-friction material or surface to prevent the user user's finger from slipping off of the contact point. In some embodiments, the user contacts the contact point with the thumb to press upwards to clean the top teeth and then uses a different finger (e.g., the index finger) to press down to clean the bottom teeth.

FIG. 14D is a perspective view of an oral hygiene device 800 d illustrating another embodiment of a handle 1410D for the device. In this embodiment, the handle comprises a recess or loop into which the user inserts a finger to manipulate the device. The axis of insertion can be either normal to the plane of the device or parallel to the plane of the device.

FIG. 15 is a top view of an embodiment of an oral hygiene device 900 that includes a single hinge 1502. In some embodiments, the device 1500 includes a single hinge 1502, rather than the dual hinges 402 previously described with reference to FIGS. 3A-4B. The single hinge 1502 can be positioned at the front of the device 1500. The single hinge 1502 can be a living hinge or a mechanical hinge. In some embodiments, the device 1500 also includes a locking mechanism to secure the device 1500 in the closed configuration.

FIG. 16A is a perspective view of an embodiment of an oral hygiene device 1600 a that includes a removable floss device 1602A that can also be used as a handle for the device. In the illustrated embodiment, the removable floss device 1602A is positioned at the front of the device 1600 a. The removable floss device 1602A comprises a C-shaped body that is connected to the body of the device 1600 a. The C-shaped body is strung with floss. The removable floss device 1602A can be gripped by the user to manipulate the device 1000 a during cleaning. Afterwards, the user may remove the removable floss device 1602A and use it to floss between teeth as desired.

FIG. 16B is a perspective view of another embodiment of an oral hygiene device 1600 b that includes a removable floss device 1602B that can also be used as a handle for the device. The removable floss device 1602B is similar to the removable floss device 1600A described above, except that the removable floss device 1602B includes an elongated handle portion 1604 that can be used to hold the removable floss device 1602B after it has been removed.

FIGS. 17A-17D illustrate oral hygiene devices that are configured to clean both sides (front and back) of the teeth, but do not clean all of the teeth at once as with the previously described oral hygiene devices. FIG. 17A illustrates a perspective view of an embodiment of a U-shaped oral hygiene device 1700 a. The device is described as U-shaped because it has a U-shaped cross-section. The U-shaped cross-section can include a body having channel formed therein. The channel can include teeth cleaning features as described above.

FIG. 17B illustrates a perspective view of another embodiment of a U-shaped oral hygiene device 1700 b that includes a handle configured to receive a finger.

FIG. 17C illustrates a perspective view of another embodiment of a U-shaped oral hygiene device 1700 c that includes a handle attached to the device by a joint. The handle can comprise a rod extending from the joint. The rod can be sufficiently long that the user does not need to reach his or her fingers into the mouth to manipulate the device. In some embodiments, the joint is a ball joint.

FIG. 17D illustrates a perspective view of an embodiment of a U-shaped oral hygiene device 1700 d that includes dual handles.

The oral hygiene device described herein can be used to clean teeth and/or freshen the mouth as described above. In some embodiments, the devices can be used as a supplement to a traditional tooth care routine, which generally involves twice daily brushing. For example, the devices can be used on-the-go, in between brushings, as a supplement to improve oral healthcare. In some embodiments, this is facilitated by the fact that the devices can be configured to be useable without requiring access to water and/or a bathroom. In addition, by reducing or eliminating the need for people to find public restrooms while on-the-go to clean their teeth, people can avoid the unsanitary conditions associated with public restrooms (such as the spread of germs and other unsanitary material due to toilet plume).

In some embodiments, the devices can be configured to provide fluoride as means to prevent tooth decay. The Global Burden of Disease Study from 2016 estimated that oral diseases affected half of the world's population (3.58 billion people) with dental caries (tooth decay) in permanent teeth being the most prevalent condition assessed. Poor oral hygiene and inadequate exposure to fluoride can have negative effects on oral health. Further, oral health is a key indicator of overall health, wellbeing and quality of life. The World Health Organization (WHO) defines oral health as “a state of being free from chronic mouth and facial pain, oral and throat cancer, oral infection and sores, periodontal (gum) disease, tooth decay, tooth loss, and other diseases and disorders that limit an individual's capacity in biting, chewing, smiling, speaking, and psychosocial wellbeing.”

Additionally, poor oral health can be even more common in developing countries, with increasing urbanization and changes in living conditions. The prevalence of oral diseases continues to increase notably due to inadequate exposure to fluoride and poor access to primary oral health care services. Heavy marketing of sugars, tobacco and alcohol also leads to growing consumption of unhealthy products.

Dental caries results when microbial biofilm (plaque) formed on the tooth surface converts the free sugars contained in foods and drinks into acids that dissolve tooth enamel and dentine over time. With continued high intake of free sugars, inadequate exposure to fluoride and without regular microbial biofilm removal, tooth structures are destroyed, resulting in development of cavities and pain, impacts on oral-health-related quality of life, and, in the advanced stage, tooth loss and systemic infection.

The burden of oral diseases and other non-communicable diseases (NCDs) can be reduced through public health interventions by addressing common risk factors. In addition, to the NCDs' common risk factors, inadequate exposure to fluoride and a number of social determinants of health should be addressed to prevent oral diseases and reduce oral health inequalities.

Dental caries can be largely prevented by maintaining a constant low level of fluoride in the oral cavity. Optimal fluoride can be obtained from different sources such as fluoridated drinking water, salt, milk and toothpaste. Twice-daily tooth brushing with fluoride-containing toothpaste (1000 to 1500 ppm) should be encouraged, although people often fail to use adequate fluoride. Long-term exposure to an optimal level of fluoride results in substantially lower incidence and prevalence of tooth decay across all ages. Accordingly, the devices described herein can be used as a supplement for applying fluoride. This is even more true for developing areas where access to water is not available.

In some embodiments, the devices can be configured to provide a dose of fluoride of approximately 1000-1500 ppm. This dose of fluoride can be included in the device, but would have to be spit out and cannot be swallowed. It may be in the dabs or beads or dispensed in another mode, such as paste coated within the channel of the device. This can greatly improve dental health in areas where access to water is limited. This may be especially helpful for children (especially since an estimated 486 million children suffer from tooth decay).

The oral hygiene devices of the present application may also be especially useful for people with limited mobility. For example, because the device is configured to clean substantially all the teeth at once, they may require less dexterity than a traditional toothbrush. Further, the devices can be used by caretakers who are cleaning the teeth of another person, such as a person in a nursing home. Use of the device can be particularly advantageous because caretaker can use the device without having to place their fingers into the person's mouth. This can reduce the time required to clean the persons teeth and freshen the mouth and clean the tongue leading to better health outcomes for the residents and better social interactions.

FIGS. 18A-18E illustrate an additional embodiment of an oral hygiene device 1800. FIG. 18A is a perspective view, FIG. 18B is a top view, FIG. 18C is a bottom view, FIG. 19D is an outside side view, and FIG. 19E is an inside side view. In many respects, the device 1800 is similar to many of the devices previously described. For example, the device 1800 may be similar to the device 700 in many respects. For ease of description, similar features are not re-described here.

As best shown in FIGS. 18A and 18E, the device 1800 can include a cutout 1821 on a rear portion of the lingual or inner wall 1820. That is, as shown, the inner wall 1820 may not extend entirely towards the back of the device 1800. It has been found during testing, that inclusion of the cutout 1821 facilitates use of the device, allowing it to clear the user's teeth better. For example, the cutout 1821 can allow the device 1800 to have an increased range of motion as it is moved side to side in the mouth. This can also increase the comfort of the device as the inner wall 1821 has been reduced in the rear portion of the device so as to not interfere or undesirably contact the mouth during use. Additionally, in some embodiments, inclusion of the cutout 1821 can allow the device 1800 to fit a wider range of mouth sizes and shapes.

In some embodiments, the cutout 1821 extends at least, at most, or about 10%, 20%, 25%, 30%, 33%, 40%, 50%, or 60% of the length of the back wall, measured from the rear most portion of the device 1800 towards the front most portion of the device.

In some embodiments, the device 1800 may comprise one or more materials having a durometer of 60 Shore A, 75 Shore A, and 90 Shore A. These durometers can refer to the material that comprises the body and/or the ribs of the device 1800. Other durometers may also be used as described above.

Additionally, in some embodiments, the surface finish of the device 1800 (e.g., the surface finish of the ribs or other portions of the device that contact the teeth during use) can be configured to have a degree of roughness. The roughness may further facilitate cleaning, such as removal of plaque. In some embodiments, the surface finish comprises an EDM (electrical discharge machining) surface finish. The surface finish may comprise, for example, a VDI surface finish of 30 (123 microinches). Other surface finishes can also be used.

Although not illustrated in FIGS. 18A-18E, in some embodiments, the ribs may include a fanned-out portion. An example is shown in FIG. 21, which is described below. The fanned portion may be positioned on the distal end of the rib and/or on the inner most surface of edge of the rib that contacts the tooth. In some embodiments, the fanned portion is included on all ribs. In other embodiments, the fanned portion is included on the front and/or rear ribs. In one example, the fanned portion is included on the ribs that correspond to the front teeth, for example, from canine to canine. The fanned portion can be configured to increase the contact area between the ribs and the teeth and may provide a more efficient cleaning. The fanned portion may comprise three prongs or nibs as shown in FIG. 21, for example, although other configurations are also possible.

In some embodiments, one or more of the ribs can include a tapered portion. The tapered portion can be positioned on the distal ends or inner surfaces or edges of the ribs. The tapered portion can be configured to fit in between teeth. In some embodiments, some of the ribs included a fanned portion while some of the ribs include a tapered portion.

In some embodiments, a portion of the outer rear ribs may flare outwardly or include a concave shape configured to follow the contours of the teeth's surface. In an embodiment, the last third of the outside ribs can include the flare or concave shape.

FIGS. 18C and 18D also illustrate an embodiment of a tongue cleaner 1825 that can be integrated into the device. As shown, the tongue cleaner 1825 can be positioned on a bottom surface of the body of the device. The tongue cleaner 1825 may be formed of a rigid material (such as the same material as the body) and may comprise a shape that can be used to scrape or clean the tongue.

FIGS. 19A-19M relate to testing that has been performed to validate the efficacy of an oral hygiene device as described herein. FIG. 19A shows top, bottom and front views of the device that was tested. As shown, the device is similar to the device 700 previously described. The embodiment tested comprised a material having a durometer of Shore 90A.

FIGS. 19B-19D identify different portions of the teeth that will be further described in the results of the testing. In particular, FIGS. 19B-19C provide an automated plaque planimetry index (APP-index). FIG. 19B illustrates the APP-index bucally (towards the cheek) on the left side of the figure, and the APP-index lingually (towards the tongue) on the right side of the figure. FIG. 19C illustrates the APP-index mesially (proximal in-between teeth, anterior site) on the left side of the figure, and the APP-index distally (proximal in-between teeth, posterior site (towards the tongue) on the right side of the figure. FIG. 19D illustrate provides an occlusal planimetrical plaque index (oPPI). In the upper portion of the figure the oPPI at the molars is shown, and in the lower portion, the oPPI at the premolars is shown.

FIGS. 19B-19D illustrate that testing for plaque reduction was assessed at 24 planimetrical fields (incisors and canines) 26 fields (premolars) and 28 fields (molars) to determine the following:

-   -   mean plaque reduction at all buccal (towards the cheek) tooth         sites;     -   mean plaque reduction at all lingual (towards the tongue) tooth         sites;     -   mean plaque reduction at the risk fields near the gum line and         approximally in-between the teeth (fields ABCDF, buccally and         lingually, FIG. 19B);     -   mean plaque reduction at all mesial sites (in-between teeth,         anterior sites, FIG. 19C);     -   mean plaque reduction at all distal sites (in-between teeth,         posterior sites, FIG. 19C);     -   mean plaque reduction at occlusal sites of premolars and molars         (chewing surfaces, FIG. 19D);     -   new oPPI; and     -   total mean plaque reduction at all five tooth sites.

Testing was conducted on the device of FIG. 19A with an occlusal force of 3.5 N for 30 seconds with a lateral and rotating movement with a 10 mm amplitude to evaluate the following:

-   -   Cleaning efficacy tooth by tooth, of all interproximal sites, of         all buccal sites and of all lingual sites;     -   Differentiation of gum line and interproximal regions         (ABCDF-fields) of buccal and lingual sites;     -   Differentiation of occlusal surfaces with planimetrical fields         KL and KLMN according to oPPI (T. LANG, S. STAUFER, B.         JENNES, P. GAENGLER, ORMED Institute of Oral Medicine at the         University of Witten/Herdecke, Witten, Germany, Assessment of         Plaque Control by Robot Simulation of Tooth Brushing, Journal of         Dental Research, 2010, Vol. 89, Special Issue B);     -   Cleaning efficacy tooth by tooth, of all interproximal sites, of         all buccal, lingual and all occlusal sites;     -   Illustration with box plots, error bars and tables;     -   Descritive statistical support only (exploratory test);     -   Report and final conclusions.

Post-brush plaque values according to Modified Navy Plaque Index (Lang et al. 2011) for teeth 48, 47, 46, 45 and 44 (molars and premolars) were recoded into variables of cleaning efficacy percentages:

-   -   PI code 0=100%     -   PI code 1=75%     -   PI code 2=25%     -   . . . of plaque removal.

In this exploratory statistical analysis means, standard deviations, medians, inter-quartile ranges (lower and upper limits) and number of valid cases are reported for the 12 variables of tooth surfaces buccal′, lingual′, mesial′, distal′, buccal risk fields ABCDF′, lingual risk fields ABCDF′, total′, K—buccally′, L—lingually′, KL—mesially′, MN—distally′ and KL-KLMN—total′ for the exploration toothbrush with 3 runs/test cycles.

Furthermore a boxplot and an error bar diagram are used to depict the distribution of plaque removal values for the exploration device.

Analysis of single teeth resp. documentation of plaque removal values of single teeth per single toothbrush is performed.

Applied statistical software package: IBM SPSS Statistics Premium, release 25, 64-bit-version.

The results are present in FIGS. 19E and 19F which show comparisons of all assessed planimetrical fields of all teeth. In these figures, the median is drawn as a line through the center of the box (median values see diagram and table 1). The box represents the middle 50% of the data values (=inter-quartile range). It is connected at both sides with the last data point within the 1,5*inter-quartile range from the first resp. third quartile. Data points outside are defined as outliers (o) (outside the 1.5*interquartile range) or extreme values (

) (outside the 3*interquartile range).

FIG. 19E is a box plot of plaque removal buccally (towards the cheek), lingually (towards the tongue), mesially (anterior, in-between the teeth), distally (posterior, in-between the teeth), at buccal and lingual risk fields ABCDF (next to the gum line), total and at occlusal surfaces with planimetrical fields KL at premolars and KLMN at molars for the tested toothbrush.

FIG. 19E illustrates Error bars of plaque removal buccally (towards the cheek), lingually (towards the tongue), mesially (anterior, in-between the teeth), distally (posterior, in-between the teeth), at buccal and lingual risk fields ABCDF (next to the gum line), total and at occlusal surfaces with planimetrical fields KL at premolars and KLMN at molars for the tested toothbrush.

Additional results are summarized in FIGS. 19G-19I. FIGS. 19J-19M present results of plaque removal for single teeth.

The device was tested at four incisors, canines, two premolars and three molars in anatomic position with clinically validated organic plaque simulation (PG-Plaque simulating young 12 h regrowth plaque). The lateral-rotating manual movement of the device within 60 s brushing was limited to 8 mm, therefore, the wisdom teeth did not have device contact.

The plaque control results were documented as plaque removal percentage in medians (FIG. 19E), means (FIG. 19F) and tables (FIGS. 19H-19I). Finally, the analysis of single teeth (incisors 31-41; canine 43; premolars 44-45; molars 46-48; FIGS. 19J-19M) shows the plaque removal percentage at buccal and lingual smooth surfaces, at mesial and distal approximal surfaces in-between the teeth, at ABCDF risk field next to the gum line buccally as well as lingually, and at occlusal surfaces of premolars (KL fields) and of molars (KLMN fields).

The mean plaque removal at buccal surfaces was 30.48%, at lingual smooth surfaces 22.75%, and in-between the teeth mesially 13.02% and distally 11.79%. The risk fields next to the gum line were cleaned by less than 10% (3.93% buccally, 7.58% lingually).

The occlusal risk fields were assessed according to the Occlusal Planimetrical Plaque Index oPPI (Lang et al. 2011) and all fields of all premolars and molars exhibited less than 49% plaque removal (Code 2).

These results demonstrate that the potential of plaque control of the device is rather high and, therefore, ORMED is offering a joint project of optimization of lamellae arrangement, saliva secretion stimulation and caries prevention.

FIGS. 20A-20D present results for another set of testing that was performed using a device similar to the device 1800 of FIGS. 18A-18E.

FIG. 21 illustrates an embodiment of a fanned portion of a rib 2100.

FIGS. 22-23B illustrate embodiments of devices 2200, 2300 include enlarged handles 2210, 2310, which can facilitate use of the device.

While the above detailed description has shown, described, and pointed out novel features of the development as applied to various embodiments, it will be understood that various omissions, substitutions, and changes in the form and details of the device or process illustrated may be made by those skilled in the art without departing from the spirit of the development. As will be recognized, the present development may be embodied within a form that does not provide all of the features and benefits set forth herein, as some features may be used or practiced separately from others. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

The foregoing description details certain embodiments of the systems, devices, and methods disclosed herein. It will be appreciated, however, that no matter how detailed the foregoing appears in text, the systems, devices, and methods may be practiced in many ways. As is also stated above, it should be noted that the use of particular terminology when describing certain features or aspects of the invention should not be taken to imply that the terminology is being re-defined herein to be restricted to including any specific characteristics of the features or aspects of the technology with which that terminology is associated.

It will be appreciated by those skilled in the art that various modifications and changes may be made without departing from the scope of the described technology. Such modifications and changes are intended to fall within the scope of the embodiments. It will also be appreciated by those of skill in the art that parts included in one embodiment are interchangeable with other embodiments; one or more parts from a depicted embodiment may be included with other depicted embodiments in any combination. For example, any of the various components described herein and/or depicted in the Figures may be combined, interchanged or excluded from other embodiments.

With respect to the use of substantially any plural and/or singular terms herein, those having skill in the art may translate from the plural to the singular and/or from the singular to the plural as is appropriate to the context and/or application. The various singular/plural permutations may be expressly set forth herein for sake of clarity.

It will be understood by those within the art that, in general, terms used herein are generally intended as “open” terms (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases “at least one” and “one or more” to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles “a” or “an” limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrases “one or more” or “at least one” and indefinite articles such as “a” or “an” (e.g., “a” and/or “an” should typically be interpreted to mean “at least one” or “one or more”); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of “two recitations,” without other modifiers, typically means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to “at least one of A, B, and C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., “a system having at least one of A, B, and C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). In those instances where a convention analogous to “at least one of A, B, or C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., “a system having at least one of A, B, or C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase “A or B” will be understood to include the possibilities of “A” or “B” or “A and B.”

All references cited herein are incorporated herein by reference in their entirety. To the extent publications and patents or patent applications incorporated by reference contradict the disclosure contained in the specification, the specification is intended to supersede and/or take precedence over any such contradictory material.

The term “comprising” as used herein is synonymous with “including,” “containing,” or “characterized by,” and is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.

All numbers expressing quantities of ingredients, reaction conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should be construed in light of the number of significant digits and ordinary rounding approaches.

The above description discloses several methods and materials of the present development. This development is susceptible to modifications in the methods and materials, as well as alterations in the fabrication methods and equipment. Such modifications will become apparent to those skilled in the art from a consideration of this disclosure or practice of the development disclosed herein. Consequently, it is not intended that this development be limited to the specific embodiments disclosed herein, but that it cover all modifications and alternatives coming within the true scope and spirit of the development. 

What is claimed is:
 1. An oral hygiene device comprising: a U-shaped body comprising a first material, the U-shaped body comprising a channel configured to receive a user's upper or lower teeth, the U-shaped body comprising a first material, wherein the channel comprises an outer wall, a bottom wall, and an inner wall, and wherein rear portions of the inner wall include a cutout; one or more teeth cleaning features over molded onto the U-shaped body, the one or more teeth cleaning features made of a second material that is softer than the first material and the one or more teeth cleaning features comprising: a plurality of ribs disposed within the channel, and one or more reservoirs holding a dab configured to freshen the user's mouth, wherein the dab is configured to be useable without water; wherein the oral hygiene device is configured to be useable without access to water or a restroom.
 2. The oral hygiene device of claim 1, wherein the first material comprises polypropylene, and wherein the second material comprises a thermoplastic elastomer (TPE) or a thermoplastic polyurethane (TPU).
 3. The oral hygiene device of claim 1, wherein the second material comprises a Shore A hardness between 80 and
 90. 4. The oral hygiene device of claim 1, further comprising one or more tongue cleaning features extending from a bottom surface of the bottom wall of the channel of the body.
 5. The oral hygiene device of claim 4, wherein the one or more tongue cleaning features comprise one or more ridges formed of the second material.
 6. The oral hygiene device of claim 1, wherein the reservoirs are configured to extend through the bottom wall of the U-shaped body.
 7. The oral hygiene device of claim 6, wherein the reservoirs are configured to extend at least 0.5 mm above and below the bottom wall of the U-shaped body.
 8. The oral hygiene device of claim 7, wherein the reservoirs comprise openings extending therethrough to facilitate release of the dab.
 9. The oral hygiene device of claim 1, wherein the dab comprises a formulation that is safe to swallow.
 10. The oral hygiene device of claim 1, wherein the dab comprises fluoride.
 11. The oral hygiene device of claim 1, wherein the one or more teeth cleaning features are configured to contact at least 50%, at least 60%, at least 75%, at least 80%, or at least 90% of the user's upper or lower teeth simultaneously.
 12. The oral hygiene device of claim 1, further comprising a handle extending from the U-shaped body.
 13. A method for freshening or cleaning a user's mouth, the method comprising: inserting an oral hygiene device into a user's mouth, the oral hygiene device comprising a U-shaped body having a channel formed therein; positioning the oral hygiene device such that the user's upper or lower teeth are positioned within the channel; moving the oral hygiene device side to side and front to back to clean the user's upper or lower teeth, wherein moving the oral hygiene device distributes a formulation from dabs in reservoirs of the oral hygiene device; flipping the oral hygiene device such that the other of the user's upper or lower teeth are positioned within the channel; and moving the oral hygiene device side to side and front to back to clean the other of the user's upper or lower teeth.
 14. The method of claim 13, wherein the method is performed without access to water or a restroom.
 15. The method of claim 13, further comprising cleaning the user's tongue with one or more tongue cleaning features of the oral hygiene device by running the one or more tongue cleaning features of the oral hygiene device over the tongue.
 16. The method of claim 13, wherein the oral hygiene device is configured to contact at least 50%, at least 60%, at least 75%, at least 80%, or at least 90% of the user's upper or lower teeth simultaneously.
 17. The method of claim 13, further comprising disposing of the oral hygiene device after use.
 18. The method of claim 13, further comprising swallowing the formulation, and wherein the formulation is safe to swallow.
 19. The method of claim 13, wherein the formulation comprises fluoride.
 20. An oral hygiene device comprising: a U-shaped body configured in size and shape to be positioned over a user's upper or lower teeth during use; and one or more teeth cleaning features extending from the body and configured to clean the user's teeth. 